Physiological data may offer medical experts an understanding of a person's wellbeing far beyond what may be gleaned by observation. For example, measuring a patient's temperature, pulse, pulse strength, respiratory rate, blood oxygen levels, tidal volume, blood pressure and various other physiological parameters may provide medical professionals a better understanding of the current state of a patient's body, vital organs and systems. Physiological data may further include measurements of biomarkers.
Physiological data also may provide early detection of a medical condition. As is the case with many medical conditions, early detection may be the difference between life and death. In the field of cancer, periodic monitoring of a patient's wellbeing may improve survival and decrease mortality by detecting cancer at an early stage when treatment is more effective. Similarly, early detection of heart disease allows the patient to change or eliminate habits that worsen their condition.
Even after a medical condition is detected, physiological data remains extremely valuable. By monitoring and analyzing a patient's symptoms and physiological measurements over an appropriate period of time, a better understanding of a patient's wellbeing or medical condition may be achieved. Monitoring a patient's symptoms and physiological measurements over a period of time will allow physicians and medical professionals to better understand the progression of the patient's medical condition and detect additional related and potentially unrelated conditions. Having a record of a patient's symptoms and physiological measurements provides an archive from which the significance and relevance of future changes may be determined.
Though physiological data may be gathered during hospital stays and office visits, the data gathered represents only glimpse into the patient's physiological wellbeing at that given period of time while the patient is in the hospital or doctor's office. With so few data points, it is difficult to truly understand how these physiological measurements are changing over time and how they relate to events and routines of a patient. Furthermore, the physiological measurements taken during a hospital stay or doctor's office visit are typically limited to non-invasive measurement mechanisms limited to the exterior of one's body. These types of measurements are often incapable of measuring interior parameters used as biomarkers such as temperature, pressure and other fluid parameters within a body cavity. Non-invasive measurements limited to the exterior of one's body typically do not serve as reliable biomarkers for conditions within the body.
Several devices have been produced that are directed to gathering specific physiological data outside of a hospital or doctor's office setting. Heart rate monitors are an example of a specific physiological measurement device used outside of the hospital setting. Heart rate monitors are typically worn by patients who have been diagnosed with a heart condition or have recently had a heart attack. Additionally, athletes are known to wear heart rate monitors for fitness purposes. Typically, heart rate monitors measure the heart rate from the exterior of the patient's body in a non-invasive manner. Some heart rate monitors are also capable of communicating to a mobile device allowing the user to view the data at a later time in a reader friendly way.
Similar in purpose is Medtronic's Reveal LINQ Insertable Cardiac Monitor device which continuously monitors a patient's heart and automatically detects and records abnormal heart rhythms. The system is implanted under the skin in the user's chest and continuously monitors a patient's heart activity in the form of an electrocardiogram (ECG). When a medical event occurs, an extracorporeal recording device is placed in close proximity to the implantable device to record the heart's rhythm during the medical episode.
Another device designed to gather specific physiological data outside of a hospital or doctor's office setting is Medtronic's Continuous Glucose Monitoring (CGM) system which measures glucose levels in real time and sends alerts to a remote monitor. The alerts include the direction glucose levels are going, early notification of oncoming lows and highs, alerts for lows or highs, and insights into how food, physical activity, medication, and illness impact glucose levels. The system consists of a glucose sensor inserted under the skin that measures glucose levels, a transmitter that sends the glucose information from the sensor to a monitor via wireless radio frequency, and a small external monitor that displays glucose levels on a screen and notifies the user if it detects that glucose is reaching a high or low limit.
While devices for measuring specific physiological parameters outside of the hospital or doctor's office setting have been developed and commercialized, these devices are only directed to measuring physiological parameters specific to the medical condition being treated or the part of the anatomy in question. Typically these devices are limited to one sensor, only measuring heart rate or glucose levels, for example. For this reason, any analysis of the data generated is often narrow in scope and directed to the medical condition being treated. While the limited data generated is helpful for better understanding that particular medical condition, it offers little to no insight into the body's overall wellbeing and how other parts of the body or systems within the body relate to the medical condition or part of the anatomy in question and therefore is often insufficient to serve as a biomarker.
Another drawback of these devices is that the monitoring or recording elements of the device are typically physically coupled to the sensing device or required to be in very close proximity to the sensing device. Where the sensing device is physically connected to the monitoring or recording element, this often requires a cable running transcutaneously from an implanted sensor to an external monitoring or recording device. The transcutaneous cable is not only painful but also could lead to infection. Additionally, the transcutaneous cable may restrict movement and hinder the user's daily activities.
In U.S. Pat. No. 9,039,652 to Degen, entitled apparatus and methods for treating intracorporeal fluid accumulation, incorporated by reference herein in its entirety, an implantable medical sensing device is configured to generate data and a charging device is configured to download the data. The implantable device disclosed in the Degen patent includes a mechanical gear pump that is configured to be coupled to the bladder and another cavity such as the peritoneal cavity. The implantable device in Degen further describes a plurality of sensors to continually monitor pressure, temperature, humidity, charge status, pump status, patient movement and other environmental and system related parameters. The plurality of sensors may communicate wirelessly with the charging device only when in close proximity. The charging device may then relay this information to a physician's computer.
Devices generally require that the monitoring or recording device be in close proximity to an implantable device. Considering that the implantable device will frequently be out of range of the monitoring and recording device, data may not be uploaded to the monitoring or recording device continuously. Accordingly, the implantable sensing device is required to include complex circuitry and memory for storing data between uploads.
Yet another drawback of these devices is that they often do not generate operational parameters to track the performance of the implanted machinery, such as an insulin pump. For example, while a Continuous Glucose Monitoring system may generate data regarding the patient's glucose levels, such systems do not measure insulin pump parameters, leaving the performance of the pump in question. Such data, if available, could be compared to the performance of the insulin pump to better optimize and understand the pump's effect on the body.
In view of the above-noted drawbacks of previously-known systems, it would be desirable to provide methods and systems for managing and analyzing physiological and operational data generated by an implantable device using a number of other computing devices not necessarily located in close proximity to the implantable device.